UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048478
Receipt number R000055222
Scientific Title A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Date of disclosure of the study information 2022/08/01
Last modified on 2023/08/14 15:57:34

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Basic information

Public title

A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity

Acronym

ACT-1 study

Scientific Title

A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity

Scientific Title:Acronym

ACT-1 study

Region

Japan


Condition

Condition

taxane-induced peripheral neurotoxicity

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in average pain intensity between baseline and week 16.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Acupuncture

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patient with breast cancer who had received curative treatment more than 3 months ago
2) Received taxane.
3) Have "mild" or severer symptom in PRO-CTCAE item 39b
4) 18 years or older
5) ECOG PS 0 or 1

Key exclusion criteria

1)Patient with peripheral neuropathy by other than taxane
2)have distant metastases or local recurrence
3)have fibromyalgia, inflammatory joint disease, or phantom limb pain
4)undergoing chemotherapy
5)have mental illness
6)have severe comorbidities
7)being pregnant or breastfeeding
8)history of acupuncture for CIPN

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Eriko
Middle name
Last name Satomi

Organization

National Cancer Center Hospital

Division name

Department of Palliative Medicine

Zip code

1040045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335422511

Email

esatomi@ncc.go.jp


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name Ishiki

Organization

National Cancer Center Hospital

Division name

Department of Palliative Medicine

Zip code

1040045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

0335422511

Homepage URL


Email

hishiki@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospiatl
Department of Palliative Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

Tel

0335422511

Email

irst@ml.res.ncc.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022 Year 06 Month 28 Day

Date of IRB

2022 Year 07 Month 22 Day

Anticipated trial start date

2022 Year 09 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 07 Month 27 Day

Last modified on

2023 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name